Vedrop

tocofersolan

  • Email
  • Help

About

This is a summary of the European public assessment report (EPAR) for Vedrop. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Vedrop.

For practical information about using Vedrop, patients should read the package leaflet or contact their doctor or pharmacist.

What is Vedrop and what is it used for?

Vedrop is a medicine used to treat or prevent vitamin E deficiency (low vitamin E levels). It is used in children up to the age of 18 years who have congenital or hereditary chronic cholestasis and who cannot absorb vitamin E from the gut. Congenital or hereditary chronic cholestasis is an inherited disease causing problems with the flow of bile from the liver to the gut. Bile is a fluid produced in the liver that helps to absorb fats from the gut.

Vedrop contains the active substance tocofersolan.

How is Vedrop used?

Vedrop can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in treating patients with congenital or hereditary chronic cholestasis.

Vedrop is available as a solution to be given by mouth. The recommended daily dose is 0.34 ml per kilogram body weight. This dose should be adjusted according to the amount of vitamin E in the patient’s blood. This should be checked regularly.

How does Vedrop work?

Vitamin E is a natural substance that cannot be made by the body and is therefore needed in the diet. It has a number of actions in the body, including protecting the nervous system from damage. Because vitamin E dissolves in fats but not in water, it can only be absorbed from the gut into the body alongside fat particles. Patients with cholestasis may have low vitamin E levels because they have problems absorbing fats from the gut.

The active substance in Vedrop, tocofersolan, is vitamin E that has been made water soluble by attaching it to a chemical called polyethylene glycol. Tocofersolan can be absorbed from the gut in children who have difficulty absorbing fats and vitamin E from the diet. This can increase vitamin E levels in the blood and help to prevent damage to the nervous system due to vitamin E deficiency.

What benefits of Vedrop have been shown in studies?

To support the use of Vedrop, the company presented information from the scientific literature, including the results of three studies in a total of 92 children and adolescents with chronic cholestasis who were given tocofersolan for about two years. All the patients had vitamin E deficiency that was not responding to other vitamin E treatments given by mouth. The main measures of effectiveness were the level of vitamin E in the blood and the number of children whose neurological symptoms improved or stayed the same. The studies showed that Vedrop could correct vitamin E levels in patients with chronic cholestasis and that it might improve or prevent neurological symptoms, especially in patients aged below three years.

The company also presented information on the use of Vedrop in patients with cystic fibrosis, but withdrew its application for this disease during the evaluation of the medicine.

What are the risks associated with Vedrop?

The most common side effect with Vedrop (which may affect up to 1 in 10 people) is diarrhoea. Vedrop must not be used in premature babies. For the full list of all side effects and restrictions with Vedrop, see the package leaflet.

Why is Vedrop approved?

The European Medicines Agency decided that Vedrop’s benefits are greater than its risks and recommended that Vedrop be given marketing authorisation.

Vedrop has been authorised under ‘exceptional circumstances’. This is because it has not been possible to obtain complete information about Vedrop due to the rarity of the disease. Every year, the European Medicines Agency will review any new information that becomes available and this summary will be updated as necessary.

What information is still awaited for Vedrop?

Since Vedrop has been approved under exceptional circumstances, the company that markets the medicine is required to provide further data on the safety and effectiveness of Vedrop in patients with congenital or hereditary chronic cholestasis.

What measures are being taken to ensure the safe and effective use of Vedrop?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vedrop have been included in the summary of product characteristics and the package leaflet.

Other information about Vedrop

The European Commission granted a marketing authorisation valid throughout the European Union for Vedrop on 24 July 2009.

For more information about treatment with Vedrop, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Vedrop : EPAR - Summary for the public BG = bălgarski 2009-08-06 2017-09-21
Vedrop : EPAR - Summary for the public ES = español 2009-08-06 2017-09-21
Vedrop : EPAR - Summary for the public CS = čeština 2009-08-06 2017-09-21
Vedrop : EPAR - Summary for the public DA = dansk 2009-08-06 2017-09-21
Vedrop : EPAR - Summary for the public DE = Deutsch 2009-08-06 2017-09-21
Vedrop : EPAR - Summary for the public ET = eesti keel 2009-08-06 2017-09-21
Vedrop : EPAR - Summary for the public EL = elliniká 2009-08-06 2017-09-21
Vedrop : EPAR - Summary for the public EN = English 2009-08-06 2017-09-21
Vedrop : EPAR - Summary for the public FR = français 2009-08-06 2017-09-21
Vedrop : EPAR - Summary for the public IT = italiano 2009-08-06 2017-09-21
Vedrop : EPAR - Summary for the public LV = latviešu valoda 2009-08-06 2017-09-21
Vedrop : EPAR - Summary for the public LT = lietuvių kalba 2009-08-06 2017-09-21
Vedrop : EPAR - Summary for the public HU = magyar 2009-08-06 2017-09-21
Vedrop : EPAR - Summary for the public MT = Malti 2009-08-06 2017-09-21
Vedrop : EPAR - Summary for the public NL = Nederlands 2009-08-06 2017-09-21
Vedrop : EPAR - Summary for the public PL = polski 2009-08-06 2017-09-21
Vedrop : EPAR - Summary for the public PT = português 2009-08-06 2017-09-21
Vedrop : EPAR - Summary for the public RO = română 2009-08-06 2017-09-21
Vedrop : EPAR - Summary for the public SK = slovenčina 2009-08-06 2017-09-21
Vedrop : EPAR - Summary for the public SL = slovenščina 2009-08-06 2017-09-21
Vedrop : EPAR - Summary for the public FI = suomi 2009-08-06 2017-09-21
Vedrop : EPAR - Summary for the public SV = svenska 2009-08-06 2017-09-21
Vedrop : EPAR - Summary for the public HR = Hrvatski 2009-08-06 2017-09-21

This EPAR was last updated on 21/09/2017 .

Authorisation details

Product details

Product details for Vedrop
NameVedrop
Agency product numberEMEA/H/C/000920
Active substance

tocofersolan

International non-proprietary name (INN) or common name

tocofersolan

Therapeutic area Vitamin E DeficiencyCholestasis
Anatomical therapeutic chemical (ATC) code A11HA08
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Exceptional Circumstances

There were "exceptional circumstances" concerning the approval of this medicine. This happens when the applicant can show that they are unable to provide comprehensive data on the efficacy and safety of the medicine for which authorisation is being sought, due to the rarity of the condition it is intended for, limited scientific knowledge in the area concerned, or ethical considerations involved in the collection of such data.

Publication details

Publication details for Vedrop
Marketing-authorisation holder

Orphan Europe S.A.R.L.

Revision10
Date of issue of marketing authorisation valid throughout the European Union24/07/2009

Contact address:

Orphan Europe S.A.R.L.
Immeuble "Le Wilson"
FR-92800 Puteaux
France

Product information

Product information

20/07/2017  Vedrop -EMEA/H/C/000920 -II/0022

Name Language First published Last updated
Vedrop : EPAR - Product Information HR = Hrvatski 2009-08-06 2017-08-02
Vedrop : EPAR - Product Information HR = Hrvatski 2009-08-06 2017-08-02
Vedrop : EPAR - Product Information HR = Hrvatski 2009-08-06 2017-08-02
Vedrop : EPAR - Product Information HR = Hrvatski 2009-08-06 2017-08-02
Vedrop : EPAR - Product Information HR = Hrvatski 2009-08-06 2017-08-02
Vedrop : EPAR - Product Information HR = Hrvatski 2009-08-06 2017-08-02
Vedrop : EPAR - Product Information HR = Hrvatski 2009-08-06 2017-08-02
Vedrop : EPAR - Product Information HR = Hrvatski 2009-08-06 2017-08-02
Vedrop : EPAR - Product Information HR = Hrvatski 2009-08-06 2017-08-02
Vedrop : EPAR - Product Information HR = Hrvatski 2009-08-06 2017-08-02
Vedrop : EPAR - Product Information HR = Hrvatski 2009-08-06 2017-08-02
Vedrop : EPAR - Product Information HR = Hrvatski 2009-08-06 2017-08-02
Vedrop : EPAR - Product Information HR = Hrvatski 2009-08-06 2017-08-02
Vedrop : EPAR - Product Information HR = Hrvatski 2009-08-06 2017-08-02
Vedrop : EPAR - Product Information HR = Hrvatski 2009-08-06 2017-08-02
Vedrop : EPAR - Product Information HR = Hrvatski 2009-08-06 2017-08-02
Vedrop : EPAR - Product Information HR = Hrvatski 2009-08-06 2017-08-02
Vedrop : EPAR - Product Information HR = Hrvatski 2009-08-06 2017-08-02
Vedrop : EPAR - Product Information HR = Hrvatski 2009-08-06 2017-08-02
Vedrop : EPAR - Product Information HR = Hrvatski 2009-08-06 2017-08-02
Vedrop : EPAR - Product Information HR = Hrvatski 2009-08-06 2017-08-02
Vedrop : EPAR - Product Information HR = Hrvatski 2009-08-06 2017-08-02
Vedrop : EPAR - Product Information HR = Hrvatski 2009-08-06 2017-08-02
Vedrop : EPAR - Product Information HR = Hrvatski 2009-08-06 2017-08-02
Vedrop : EPAR - Product Information HR = Hrvatski 2009-08-06 2017-08-02

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Vedrop : EPAR - All Authorised presentations HR = Hrvatski 2009-08-06  
Vedrop : EPAR - All Authorised presentations HR = Hrvatski 2009-08-06  
Vedrop : EPAR - All Authorised presentations HR = Hrvatski 2009-08-06  
Vedrop : EPAR - All Authorised presentations HR = Hrvatski 2009-08-06  
Vedrop : EPAR - All Authorised presentations HR = Hrvatski 2009-08-06  
Vedrop : EPAR - All Authorised presentations HR = Hrvatski 2009-08-06  
Vedrop : EPAR - All Authorised presentations HR = Hrvatski 2009-08-06  
Vedrop : EPAR - All Authorised presentations HR = Hrvatski 2009-08-06  
Vedrop : EPAR - All Authorised presentations HR = Hrvatski 2009-08-06  
Vedrop : EPAR - All Authorised presentations HR = Hrvatski 2009-08-06  
Vedrop : EPAR - All Authorised presentations HR = Hrvatski 2009-08-06  
Vedrop : EPAR - All Authorised presentations HR = Hrvatski 2009-08-06  
Vedrop : EPAR - All Authorised presentations HR = Hrvatski 2009-08-06  
Vedrop : EPAR - All Authorised presentations HR = Hrvatski 2009-08-06  
Vedrop : EPAR - All Authorised presentations HR = Hrvatski 2009-08-06  
Vedrop : EPAR - All Authorised presentations HR = Hrvatski 2009-08-06  
Vedrop : EPAR - All Authorised presentations HR = Hrvatski 2009-08-06  
Vedrop : EPAR - All Authorised presentations HR = Hrvatski 2009-08-06  
Vedrop : EPAR - All Authorised presentations HR = Hrvatski 2009-08-06  
Vedrop : EPAR - All Authorised presentations HR = Hrvatski 2009-08-06  
Vedrop : EPAR - All Authorised presentations HR = Hrvatski 2009-08-06  
Vedrop : EPAR - All Authorised presentations HR = Hrvatski 2009-08-06  

Pharmacotherapeutic group

Vitamins

Therapeutic indication

Vedrop is indicated in vitamin-E deficiency due to digestive malabsorption in paediatric patients suffering from congenital chronic cholestasis or hereditary chronic cholestasis, from birth (in term newborns) to 16 or 18 years of age, depending on the region.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Vedrop : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2011-04-19 2017-08-02

Initial marketing-authorisation documents

Name Language First published Last updated
Vedrop : EPAR - Public assessment report HR = Hrvatski 2009-08-06  
Committee for medicinal products for human use, summary of positive opinion for Vedrop HR = Hrvatski 2009-05-29  

Authorised

This medicine is approved for use in the European Union